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Health Law News

Off-Label Use of Medical Products: Warranty and Indemnification Considerations in Purchase Agreements

[04/11/13]

Posted on April 11, 2013 in Health Law News

Published by: Hall Render

When you purchase an item, you assume that it can be used in any reasonable manner and the warranties will apply.  The same is true of buyers of medical products.  Take the humble tongue depressor.  Regulated by the Food and Drug Administration (“FDA”) pursuant to 21 C.F.R. § 800.6230, the tongue depressor is “…a... READ MORE

Michigan Strengthens Its Certification Requirements for Sign Language Interpreters

[04/11/13]

Posted on April 11, 2013 in Health Law News

Published by: Hall Render

Under the Americans with Disabilities Act (“ADA”)1,health care providers have an obligation to provide the deaf and hard of hearing with auxiliary aids needed to access and understand aural information and to engage in effective communication.2  Auxiliary aids include, among other things, qualified interpreters.  Under federal law, a “qualified interpreter” is defined as an... READ MORE

HRSA Extends 340B GPO Exclusion Guidance Compliance Deadline from April 7, 2013 to August 7, 2013

[04/08/13]

Posted on April 8, 2013 in Health Law News

Published by: Hall Render

On February 7, 2013, the United States Health Resources and Services Administration (“HRSA”) released guidance entitled “Statutory Prohibition on Group Purchasing Organization Participation” (“GPO Exclusion Guidance”).  This guidance addresses requirements related to drugs purchased at a discount under the 340B Program by hospitals subject to the 340B Program GPO exclusion restriction.  These include disproportionate... READ MORE

Unpaid Medical Intern Is Not an Employee under the Health Care Worker Protection Act

[04/05/13]

Posted on April 5, 2013 in Health Law News

Published by: Hall Render

Executive Summary In Masri v. LIRC, 2012AP1047 (April 2, 2013), the Wisconsin Court of Appeals affirmed a decision by the Labor and Industry Review Commission (“LIRC”) that Wisconsin’s Health Care Worker Protection Act (“HCWPA”) applies only to employees of health care facilities and that an unpaid intern is not an employee for purposes of... READ MORE

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New Proposed Regulations on Code Section 501(r) Released

[04/04/13]

Posted on April 4, 2013 in Health Law News

Published by: Hall Render

On Wednesday, April 3, the Internal Revenue Service (“IRS”) released a new round of Proposed Regulations that expand upon, and address uncertainties regarding, the requirements of Code Section 501(r) applicable to tax-exempt hospital organizations. These new Proposed Regulations provide guidance on the community health needs assessment requirements and related excise tax and reporting obligations.... READ MORE

Medicare Issues Guidance to Hospitals for Part B Rebilling of Denied Inpatient Claims

[03/28/13]

Posted on March 28, 2013 in Health Law News

Published by: Hall Render

Following the recent CMS Administrator’s Ruling CMS-1455-R, CMS issued a Program Transmittal with claims processing instructions related to the rebilling of denied inpatient claims under the interim rebilling policy.  A corresponding article intended for hospitals was released on March 22, 2013 and can be found on the CMS website here. READ MORE

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OIG Releases Physician-Owned Entity Special Fraud Alert

[03/27/13]

Posted on March 27, 2013 in Health Law News

Published by: Hall Render

Executive Summary On March 26, 2013, the Office of Inspector General (“OIG”) released a special fraud alert (“Alert”) regarding physician-owned distributorships (“PODs”). PODs are entities that sell, or arrange for the sale of, implantable medical devices that may be used by the physician-owners or others for procedures on patients in hospitals and ambulatory surgery centers... READ MORE

New I-94 Arrival/Departure Record to Be Automated

[03/22/13]

Posted on March 22, 2013 in Health Law News

Published by: Hall Render

U.S. Customs and Border Protection (“CBP”) announced today that it has submitted a rule to the Federal Register that will automate Form I-94 Arrival/Departure Record. Automation of the current paper-based process will streamline the admissions protocol for individuals lawfully visiting the United States. The automation means that affected visitors will no longer need to... READ MORE

Wisconsin Hospitals May Maintain a Statutory Lien on a Medicare-Eligible Patient’s Personal Injury Claims after the Medicare Billing Period Expires

[03/18/13]

Posted on March 18, 2013 in Health Law News

Published by: Hall Render

In Laska v. General Casualty Company of Wisconsin, No. 2010AP2410, slip op. (WI App Mar. 14, 2013), the Wisconsin Court of Appeals held that charitable hospitals may, instead of billing Medicare for treatment of a patient, pursue payment by filing a statutory lien against any tort claims and any settlement or judgment resulting from... READ MORE

Hospital Value-Based Purchasing Metrics for Fiscal Year 2015 Are Underway

[03/15/13]

Posted on March 15, 2013 in Health Law News

Published by: Hall Render

On October 1, 2012, the Centers for Medicare and Medicaid Services (“CMS”) began withholding 1% of hospital Medicare reimbursement payments as a part of the Value-Based Purchasing (“VBP”) program. The withheld amount will increase 0.25% each fiscal year until it is capped at 2% for FY 2017. Under the VBP program, hospitals compete with one... READ MORE